Gemcitabine STADA

Medicinal product

(Invented) name

Gemcitabine STADA

Active substance (s)

Gemcitabinas

Strength

38 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BC05, Gemcitabine

Marketing authorisation holder

STADA Arzneimittel AG, Vokietija

Date of authorisation

2010-03-05

Date of renewal

2022-01-28

Documents

1894_Gemcitabine STADA_perr2022-01-28.docx

1894_ pakuotes lapelis_2022-01-28.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/5530/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Gemcitabinas	38 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
29550	32042	1032042	buteliukas	5,26 ml N1		Receptinis	LT/1/10/1894/001	Netiekiama	-	-	No	-	-
30675	33135	1033135	buteliukas	26,3 ml N1		Receptinis	LT/1/10/1894/002	Netiekiama	-	-	No	-	-
30676	33136	1033136	buteliukas	39,5 ml N1		Receptinis	LT/1/10/1894/003	Netiekiama	-	-	No	-	-
30677	33137	1033137	buteliukas	52,6 ml N1		Receptinis	LT/1/10/1894/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-03-31	Išregistruotas
2022-01-28	Perregistruotas
2010-03-05	Registruotas